Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Instrument, Ultrasonic Surgical
510(k) Number K211273
Device Name Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray
Applicant
Ethicon Endo-Surgery, LLC
475 Calle C
Guaynabo,  PR  00969
Applicant Contact Nathan Anderson
Correspondent
Ethicon Endo-Surgery, Inc.
4545 Creek Rd.
Blue Ash,  OH  45242
Correspondent Contact Ruth James
Classification Product Code
LFL  
Date Received04/27/2021
Decision Date 05/21/2021
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-